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Background There is an ethical imperative to offer the results of trials to those who participated. Existing research highlights that less than a third of trials do so, despite the desire of participants to receive the results of the trials they participated in. This scoping review aimed to identify, collate, and describe the available evidence relating to any aspect of disseminating trial results to participants. Methods A scoping review was conducted employing a search of key databases (MEDLINE, EMBASE, PsycINFO, and the Cumulative Index to Nursing & Allied Health Literature (CINAHL) from January 2008 to August 2019) to identify studies that had explored any aspect of disseminating results to trial participants. The search strategy was based on that of a linked existing review. The evidence identified describes the characteristics of included studies using narrative description informed by analysis of relevant data using descriptive statistics. Results Thirty-three eligible studies, including 12,700 participants (which included patients, health care professionals, trial teams), were identified and included. Reporting of participant characteristics (age, gender, ethnicity) across the studies was poor. The majority of studies investigated dissemination of aggregate trial results. The most frequently reported mode of disseminating of results was postal. Overall, the results report that participants evaluated receipt of trial results positively, with reported benefits including improved communication, demonstration of appreciation, improved retention, and engagement in future research. However, there were also some concerns about how well the dissemination was resourced and done, worries about emotional effects on participants especially when reporting unfavourable results, and frustration about the delay between the end of the trial and receipt of results. Conclusions This scoping review has highlighted that few high-quality evaluative studies have been conducted that can provide evidence on the best ways to deliver results to trial participants. There have been relatively few qualitative studies that explore perspectives from diverse populations, and those that have been conducted are limited to a handful of clinical areas. The learning from these studies can be used as a platform for further research and to consider some core guiding principles of the opportunities and challenges when disseminating trial results to those who participated.

ObjectiveTo generate stakeholder informed evidence to support recommendations for trialists to implement the dissemination of results summaries to participants.DesignA multiphase mixed-methods triangulation design involving Q-methodology, content analysis, focus groups and a coproduction workshop (the REporting Clinical trial results Appropriately to Participants project).SettingPhase III effectiveness trials.ParticipantsA range of participants were included from ongoing and recently completed trials, public contributors, trialists, sponsors, research funders, regulators, ethics committee members.ResultsFewer than half of the existing trial result summaries contained information on the clinical implications of the study results, an item deemed to be of high importance to participants in the Q-methodology study. Priority of inclusion of a thank you message varied depending on whether considering results for individuals or populations. The need for personally responsive modes of sharing trial result summaries was highlighted as important. Ideally, participants should be the first to know of the results with regard to the timing of sharing results summaries but given this can be challenging it is therefore important to manage expectations. In addition to patients, it was identified that it is important to engage with a range of stakeholders when developing trial results summaries.ConclusionsResults summaries for trial participants should cover four core questions: (1) What question the trial set out to answer?; (2) What did the trial find?; (3) What effect have the trial results had and how will they change National Health Service/treatment?; and (4) How can I find out more? Trial teams should develop appropriately resourced plans and consult patient partners and trial participants on how ‘best’ to share key messages with regard to content, mode, and timing. The study findings provide trial teams with clear guidance on the core considerations of the ‘what, how, when and who’ with regard to sharing results summaries.

Community mental health teams (CMHTs) in England face mounting service pressures due to an increased focus on out-of-hospital care. Interprofessional working is essential to providing good mental healthcare in community settings. Simulation training is underused in mental health, despite strong support for its improvement of clinical skills, confidence, teamwork, and interprofessional collaboration in other healthcare settings. This study aims to evaluate the impact of simulation training on community mental health professionals. An interprofessional simulation training course on assessment and team working skills for community mental health professionals was developed and delivered at a time of service reorganisation in South London services, including changes to job roles and responsibilities. In total, 57 course participants completed a survey that measured perceptions of knowledge and confidence, as well as a general view of the course. Eight participants took part in further semi-structured interviews 2-3 months after the course to provide perceptions about this experience's subsequent impact. There were statistically significant increases in knowledge and confidence scores with large effect sizes. Thematic analyses of open-text survey and interview data identified emergent themes of interprofessional understanding; attitudes in clinical practice; staff well-being; the value of reflection; opportunity for feedback; and fidelity to clinical practice. Simulation training can improve confidence and knowledge in core skills and team working for CMHTs. Participants reported benefits to key areas of community mental healthcare, such as interprofessional collaboration, reflective practice, and staff well-being. Findings represented individual and team learning, as well as subsequent changes to clinical practice, and were related back to the interactive and reflective nature of the simulation. Implications are highlighted concerning the use of interprofessional simulation training in mental health, particularly relating to staff well-being, attitudes, and interprofessional working.

This article is a report of the fourth meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in Malmo, Sweden on 23-24 April 2015 (HOME IV). The aim of the meeting was to achieve consensus over the preferred outcome instruments for measuring patient-reported symptoms and quality of life for the HOME core outcome set for atopic eczema (AE). Following presentations, which included data from systematic reviews, consensus discussions were held in a mixture of whole group and small group discussions. Small groups were allocated a priori to ensure representation of different stakeholders and countries. Decisions were voted on using electronic keypads. For the patient-reported symptoms, the group agreed by vote that itch, sleep loss, dryness, redness/inflamed skin and irritated skin were all considered essential aspects of AE symptoms. Many instruments for capturing patient-reported symptoms were discussed [ including the Patient-Oriented SCOring Atopic Dermatitis index, Patient-Oriented Eczema Measure (POEM), Self-Administered Eczema Area and Severity Index, Itch Severity Scale, Atopic Dermatitis Quickscore and the Nottingham Eczema Severity Score] and, by consensus, POEM was selected as the preferred instrument to measure patient-reported symptoms. Further work is needed to determine the reliability and measurement error of POEM. Further work is also required to establish the importance of pain/soreness and the importance of collecting information regarding the intensity of symptoms in addition to their frequency. Much of the discussion on quality of life concerned the Dermatology Life Quality Index and Quality of Life Index for Atopic Dermatitis; however, consensus on a preferred instrument for measuring this domain could not be reached. In summary, POEM is recommended as the HOME core outcome instrument for measuring AE symptoms.

Objectives To determine the prevalence, severity and remission of desire for hastened death (DHD) in a UK representative sample of patients with advanced disease receiving palliative care and to examine the associations of desire for death. Design A cross-sectional survey with 4-week follow-up. Setting St Christopher9s Hospice, Sydenham, South London, which is a large hospice with homecare, outpatient and inpatient facilities serving five London boroughs. Participants 300 patients newly referred to the hospice for palliative care. Main outcome measures The Desire for Death Rating Scale (DDRS). Results At T1 33/300 (11%) reported DHD and 11/300 (3.7%) had more serious or pervasive DHD. Of those who expressed DHD at T1 and were interviewed at both time points, 35% no longer reported these thoughts. Of those who reported no DHD at T1, 8% reported DHD at T2. The majority of those who had more severe DHD at T1 had a reduced DHD score by T2. Factors associated with T1 DHD included presence of non-malignant disease, depression, more severe physical symptoms, hopelessness and perceived loss of dignity. Conclusions The prevalence of DHD was at the lower end of that seen in previous studies using similar samples. More severe DHD was uncommon and for most part remitted to some extent during the study. The provision of symptom control and timely detection and intervention for depression coupled with a focus on optimising function, instilling hope and preserving dignity are likely to contribute to alleviation of DHD in patients with advanced illness.

Background The Harmonising Outcome Measures for Eczema (HOME) initiative has identified quality of life (QoL) as a core outcome domain to be evaluated in every eczema trial. It is unclear which of the existing QoL instruments is most appropriate for this domain. Thus, the aim of this review was to systematically assess the measurement properties of existing measurement instruments developed and/or validated for the measurement of QoL in adult eczema. Methods We conducted a systematic literature search in PubMed and Embase identifying studies on measurement properties of adult eczema QoL instruments. For all eligible studies, we assessed the adequacy of the measurement properties and the methodological quality with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. A best evidence synthesis summarizing findings from different studies was the basis to assign four degrees of recommendation (A–D). Results A total of 15 articles reporting on 17 instruments were included. No instrument fulfilled the criteria for category A. Six instruments were placed in category B, meaning that they have the potential to be recommended depending on the results of further validation studies. Three instruments had poor adequacy in at least one required adequacy criterion and were therefore put in category C. The remaining eight instruments were minimally validated and were thus placed in category D. Conclusions Currently, no QoL instrument can be recommended for use in adult eczema. The Quality of Life Index for Atopic Dermatitis (QoLIAD) and the Dermatology Life Quality Index (DLQI) are recommended for further validation research.

Background We developed an interprofessional simulation-based training (SBT) to promote collaboration when caring for patients in mental health crisis in the Emergency Department (ED). The intervention was run both in vivo and in a purpose-built simulation suite. The primary analysis of educational outcomes has been presented elsewhere. 1 Aims To compare participant learning outcomes and experiences from in vivo versus simulation suite delivered SBT. Methods A SBT was developed in which participants engaged in three scenarios of a simulated patient’s journey through the ED followed by structured debriefs. One course was delivered in vivo whilst three courses, with identical content and format, were delivered in a simulation suite. Participants completed pre- and post-course questionnaires, measuring changes in knowledge, confidence and attitudes. Individual participant overall change in knowledge, confidence and attitudes were compared for both participant groups using Independent-Samples T and Mann Whitney U Tests. Post-course focus groups were conducted to gather qualitative data on participant experience. Results 12 participants engaged in in vivo training versus 25 participants in simulation suite training. The professional mix was similar for both groups. The distribution of change in knowledge and self-rated confidence scores and attitudinal shift was not significantly different for in vivo and simulation suite groups ( p = 0 .64; p = 0 0.92; p = 0 .58). Views on the relative merits of in vivo versus simulation suite training were divergent. Participants from both groups recognised the tension between achieving environmental fidelity with in vivo simulation and the potential detrimental impact of managing distractions on learning. Conclusion Previous work has demonstrated that SBT effectively increases participants’ self-rated confidence and leads to positive attitudinal changes when caring for patients in mental health crisis in the ED. 1 Our results suggest that the effectiveness of learning does not appear to be different for in vivo versus simulation suite delivered training. Reference Humphreys RA, Piette A, Wilson C, Kowalski C, Cross S. Mental health crisis in the emergency department: outcomes from a new interprofessional simulation. Royal College of Psychiatrists International Congress, 2015

Background The use of simulation in mental health education is increasing. In view of changing working patterns and complex care pathways in mental health, an interprofessional approach is crucial. There is little research looking at participants’ experience of interprofessional mental health simulation (IMHS). Examining the pedagogical aspects of IMHS will allow for better understanding of its uses. Methodology Using existing guidelines, we developed a number of IMHS courses for a variety of mental health and other healthcare professionals. The majority of these were one-day interprofessional courses which used established debriefing models to promote learning and reflection. Using a variety of qualitative methods, including focus groups, semi-structured interviews and evaluation forms, we collected feedback from 206 participants to explore their experience of IMHS. A thematic analysis was completed by three independent researchers. Results IMHS was found to be a novel and stimulating learning experience. Participants reported a lack of existing training opportunities around mental health. The psychological fidelity and applicability of the scenarios to real life was highlighted, as was the opportunity to practise managing anxiety-inducing situations. Participants valued learning with and from others in a non-judgemental environment. Taking part led to participants feeling better understood by their colleagues and promoted reflection on individual areas for development. The importance of validation of feelings and the provision of a reflective space was identified along with few opportunities for this elsewhere. Some participants felt lacking in their existing knowledge base which led to them not having achieved their personal learning objectives. Conclusions Our results show that IMHS is highly valued by learners. Its interprofessional nature directly addresses the complexity of mental healthcare provision. However, the variable baseline knowledge of participants poses challenges to meeting the learning objectives of all. A balance between simulation and didactic teaching methods is required. References Wadell A, Hodges BD. Psychiatric education and simulation: a review of the literature. Can J Psychiatry 2008;53(2):85–93 Hammick M, Freeth D, Koppel I, Reeves S, Barr H. A best evidence systematic review of interprofessional education: BEME Guide no. 9. Med Teacher 2007;29(8):735–751 Salas E, Wilson KA, Burke CS, Priest HA. Using simulation-based training to improve patient safety: what does it take? Jt Comm J Qual Patient Saf 2005;31(7):363–371

Background Simulation has not been widely integrated into the core educational program of mental health trusts. In order to ensure sustainability of simulation in mental health, integration into the routine fabric of healthcare delivery is key. 1 Rigorous measurement of outcomes is essential in ensuring that simulation is adopted by managers and policy makers. We aimed to develop, run and evaluate a number of simulation courses for community mental health staff across NHS mental health trusts ensuring that learning objectives matched the desired outcomes for key stake-holders. Methods We designed and developed an inter-professional training course for community mental health workers in line with desired learning outcomes at a time of service reorganisation within the trust. We developed questionnaires measuring knowledge and confidence, which were completed before and immediately after the training course. 9 participants from different disciplines took part in semi-structured interviews 2–3 months after the course. Transcripts were analysed using thematic analysis. Results This course ran on six occasions (n = 49). Knowledge scores increased from ( M = 5.05, SD = 1.56) to ( M = 6.24, SD = 1.60) p = 0 .000, with a large effect size (0.36). There was a statistically significant increase in confidence scores following the training, z = –4.728, p = 0 .000, with a large effect size ( r = 0 .54). Iterative improvements were made to the course as a result of evaluation. Emergent themes from interviews were; learning from others, reflection on ways to improve systems, staff wellbeing and appreciation of the patient perspective. As a result of this evaluation, the course has been embedded as mandatory training within one South London mental health trust. Conclusions Simulation for community mental health teams can improve knowledge and confidence in clinical skills and was valued by staff at a time of service reconfiguration. By involving stake-holders in course design and demonstrating outcomes, simulation can be embedded within mental health service training and delivery. Reference Gaba DM. The future vision of simulation in healthcare. Simulat Healthc 2. 2 2007;126–135

Background Eczema is a common chronic or chronically relapsing, inflammatory skin disease that exerts a substantial negative impact on quality of life (QoL). The Harmonising Outcome Measures for Eczema (HOME) initiative has used a consensus-based process which identified QoL as one of the four core outcome domains to be assessed in all eczema clinical trials. A number of measurement instruments exist to measure QoL in infants, children, and adolescents with eczema, and there is a great variability in both content and quality of the instruments used. Therefore, the objective of the proposed research is to comprehensively and systematically assess the measurement properties of the existing measurement instruments that were developed and/or validated for the measurement of patient-reported QoL in infants, children, and adolescents with eczema. Methods/design This study is a systematic review of the measurement properties of patient-reported measures of QoL developed and/or validated for infants, children, and adolescents with eczema. A systematic literature search will be carried out in MEDLINE via PubMed and EMBASE using a selection of relevant search terms. Eligible studies will be primary empirical studies evaluating, describing, or comparing measurement properties of QoL instruments for infants, children, and adolescents with eczema. Two reviewers will independently perform eligibility assessment and data abstraction. Evidence tables will be used to record study characteristics, instrument characteristics, measurement properties, and interpretability. The adequacy of the measurement properties will be assessed using predefined criteria. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist will be used to evaluate the methodological quality of included studies. A best evidence synthesis will be undertaken if more than one study has examined a particular measurement property. Discussion The proposed systematic review will yield a comprehensive assessment of measurement properties of existing QoL instruments in infants, children, and adolescents with eczema. The results will serve as a basis to recommend a QoL measurement instrument for infants, one for children, and one for adolescents for use in future clinical trials. Systematic review registration PROSPERO CRD42015023483 Electronic supplementary material The online version of this article (doi:10.1186/s13643-016-0202-z) contains supplementary material, which is available to authorized users.

Background Eczema is a common chronic or chronically relapsing skin disease that has a substantial impact on quality of life (QoL). By means of a consensus-based process, the Harmonising Outcome Measures in Eczema (HOME) initiative has identified QoL as one of the four core outcome domains to be assessed in all eczema trials (Allergy 67(9):1111-7, 2012). Various measurement instruments exist to measure QoL in adults with eczema, but there is a great variability in both content and quality (for example, reliability and validity) of the instruments used, and it is not always clear if the best instrument is being used. Therefore, the aim of the proposed research is a comprehensive systematic assessment of the measurement properties of the existing measurement instruments that were developed and/or validated for the measurement of patient-reported QoL in adults with eczema. Methods/Design This study is a systematic review of the measurement properties of patient-reported measures of QoL developed and/or validated for adults with eczema. Medline via PubMed and EMBASE will be searched using a selection of relevant search terms. Eligible studies will be primary empirical studies evaluating, describing, or comparing measurement properties of QoL instruments for adult patients with eczema. Eligibility assessment and data abstraction will be performed independently by two reviewers. Evidence tables will be generated for study characteristics, instrument characteristics, measurement properties, and interpretability. The quality of the measurement properties will be assessed using predefined criteria. Methodological quality of studies will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. A best evidence synthesis will be undertaken if more than one study has investigated a particular measurement property. Discussion The proposed systematic review will produce a comprehensive assessment of measurement properties of existing QoL instruments in adult patients with eczema. We aim to identify one best currently available instrument to measure QoL in eczema patients. Systematic review registration PROSPERO CRD42015017138. Electronic supplementary material The online version of this article (doi:10.1186/s13643-015-0041-3) contains supplementary material, which is available to authorized users.

The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence-based dermatology. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes research. In June 2011, the HOME initiative conducted a consensus study involving 43 individuals from 10 countries, representing different stakeholders (patients, clinicians, methodologists, pharmaceutical industry) to determine core outcome domains for atopic eczema trials, to define quality criteria for atopic eczema outcome measures and to prioritize topics for atopic eczema outcomes research. Delegates were given evidence-based information, followed by structured group discussion and anonymous consensus voting. Consensus was achieved to include clinical signs, symptoms, long-term control of flares and quality of life into the core set of outcome domains for atopic eczema trials. The HOME initiative strongly recommends including and reporting these core outcome domains as primary or secondary endpoints in all future atopic eczema trials. Measures of these core outcome domains need to be valid, sensitive to change and feasible. Prioritized topics of the HOME initiative are the identification/development of the most appropriate instruments for the four core outcome domains. HOME is open to anyone with an interest in atopic eczema outcomes research.

At the current level of membership examination fees at the Royal College of Psychiatrists, a resident in psychiatry who passes every part first time pays a total of £2136.[1][1] These costs are intended to cover only expenses rather than to generate profit, a message which many of us have accepted

Traditional Chinese herbal mixtures have been used to treat atopic eczema for many years. Their efficacy has attracted public attention and recently some clinical trials have been undertaken.To assess the effects of Chinese herbal mixtures in the treatment of atopic eczema.We searched the Cochrane Central Register of Controlled Trials (CENTRAL) ( January 2004), the Cochrane Skin Group Specialised Register (January 2004), MEDLINE (1966 to January 2004), EMBASE (1980 to January 2004), CINHL (1980 to January 2004) and a number of complementary medicine databases. In addition, the cited references of all trials identified and key review articles were searched. Pharmaceutical companies involved in oral traditional Chinese herbs and experts in the field were contacted.Randomised controlled trials of Chinese herbal mixtures used in the treatment of atopic eczema.Two reviewers independently applied eligibility criteria, assessed the quality of the trials and extracted data. Any discrepancies were discussed to achieve consensus.Four randomised controlled trials, with eight weeks for each phase, met the inclusion criteria. The trials randomised 159 participants aged from 1 to 60 years. The withdrawal rates ranged from 7.5% to 22.5% and no trial used intention to treat analysis. Three trials were randomised placebo controlled, two-phase cross-over designs assessing the same Chinese herbal mixture, Zemaphyte. In two of these three trials the reduction in erythema and surface damage was greater on Zemaphyte than on placebo, and participants slept better and expressed a preference for Zemaphyte. One trial also reported that participants itched less. The fourth trial was an open-label design comparing Zemaphyte in herbal form with Zemaphyte as a freeze dried preparation. There was a reduction in erythema and surface damage with both formulations, but no comparison between the two formulations was reported. Some adverse effects were reported in all four trials, but none were regarded as serious.Chinese herbal mixtures may be effective in the treatment of atopic eczema. However, only four small poorly reported RCTs of the same product, Zemaphyte, were found and the results were heterogeneous. Further well-designed, larger scale trials are required, but Zemaphyte is no longer being manufactured.